Moderna says clinical data reinforce FDA approval of 2025-2026 Spikevax formula

Moderna (MRNA) announced “positive” preliminary immunogenicity data for the 2025-2026 formula of Spikevax, which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. “The data from an ongoing Phase 4 clinical trial evaluating the safety, tolerability and immunogenicity of the 2025-2026 formula of Spikevax showed, on average, greater than an 8-fold increase in neutralizing antibodies against the LP.8.1 variant in individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. The safety profile of the vaccine was consistent with previous studies, with no new safety concerns identified. Recent surveillance data from the U.S. Centers for Disease Control and Prevention shows the U.S. wastewater viral activity for COVID-19 is high, and LP.8.1 and its familial strains, XFG and NB.1.8.1, continue to dominate. This preliminary analysis confirms Moderna’s updated COVID-19 vaccine is a strong match to today’s top circulating strains in the U.S. These clinical findings also reinforce preclinical data that supported the recent U.S. Food and Drug Administration approval of the 2025-2026 formula of Spikevax, which is approved by the FDA for individuals 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. Spikevax has also been granted approval by regulators in Canada, Europe, Japan, Mexico, Switzerland and more,” the company stated.